CAJ | 학술논문

目的探讨中晚期宫颈癌患者同期放化疗中适合中国人的顺铂单药化疗每周方案剂量.方法 ⅠB2～ⅣA期需放疗的宫颈癌患者为研究对象.Ⅰ期临床试验(15例)为剂量递增试验,顺铂剂量以20、25、30、35、40 mg/m2逐渐递增(≥3例/剂量),40 mg/m2后不再增加剂量.依据Ⅰ期临床试验所得出的最大耐受剂量(40 mg/m2)进行Ⅱ期临床试验(36例).盆腔放疗采用三维适形方法.结果 Ⅰ期临床试验剂量递增至顺铂40 mg/m2未出现限制性不良反应.Ⅱ期临床试验中住院的9例患者都完成了6周化疗,门诊治疗的27例患者18例完成6周化疗,19例完成5周化疗,25例完成4周化疗.所有患者都完成了放疗.主要不良反应为1、2级胃肠道反应与白细胞减少.结论应用顺铂单药每周方案同期放化疗中晚期宫颈癌,大部分中国人能耐受40 mg/m2的同期化疗剂量,对不能住院治疗体质较弱者化疗剂量应适当减量.
목적 탐토중만기궁경암환자동기방화료중괄합중국인적순박단약화료매주방안제량.방법 ⅠB2～ⅣA기수방료적궁경암환자위연구대상.Ⅰ기림상시험(15례)위제량체증시험,순박제량이20、25、30、35、40 mg/m2축점체증(≥3례/제량),40 mg/m2후불재증가제량.의거Ⅰ기림상시험소득출적최대내수제량(40 mg/m2)진행Ⅱ기림상시험(36례).분강방료채용삼유괄형방법.결과 Ⅰ기림상시험제량체증지순박40 mg/m2미출현한제성불량반응.Ⅱ기림상시험중주원적9례환자도완성료6주화료,문진치료적27례환자18례완성6주화료,19례완성5주화료,25례완성4주화료.소유환자도완성료방료.주요불량반응위1、2급위장도반응여백세포감소.결론 응용순박단약매주방안동기방화료중만기궁경암,대부분중국인능내수40 mg/m2적동기화료제량,대불능주원치료체질교약자화료제량응괄당감량.
Objective To define the maximum tolerated dose (MTD) of weekly cisplatin in concurrent chemoradiotherapy for Chinese cervical carcinoma.Methods Cervical carcinoma of stage ⅠB2- ⅣA were eligible for the study.Phase Ⅰ study was dose-escalation trial with 15 patients.All patients received whole pelvic radiotherapy with three dimentional conformal radiotherapy technique. Concurrent cisplatin started from the dose of 20 mg/m2 to 25 mg/m2,30 mg/m2,35 mg/m2,40 mg/m2 for the weekly schedule ( ≥3 patients per dose group) and the doses were steadily escalated to 40 mg/.m2.If the dose was increased to 40 mg/m2 without dose-limiting toxicity ( DLT),40 mg/m2 would be the maximum tolerated dose (MTD).According to the MTD dose from Phase Ⅰ study,we conducted phase Ⅱ clinical trial with 36 patients.Results In Phase Ⅰ study,cisplatin dose was escalated to 40 mg/m2 and DLT had not been reached.Thirty-six patients in Phase Ⅱ study included 9 inpatients and 27 outpatients.All 9 inpatients completed 6 cycles of chemotherapy. In 27 outpatients,18 patients (66％) completed 6 cycles of chemotherapy,19 patients (70％) completed 5 cycles and 25 patients (92％) completed 4 cycles of chemotherapy.All patients completed radiotherapy.Major adverse effects were grade 1 and 2 gastrointestinal toxicities and neutropenia.Conclusions Weekly 40 mg/m2 cisplatin concurrent with radiotherapy is well tolerated when given to Chinese patients with cervical carcinoma. For outpatients with poor performance status,the cisplatin dose needs to be reduced.